Expanding capacities for cancer therapy

As a long-time partner in the battle against cancer, we at Heraeus Precious Metals business line Pharmaceutical Ingredients have made a significant investment into our new state-of-the-art production line for platinum containing highly active pharmaceutical ingredients (hAPIs). Take a sneak peek of our new facilities in our video.

"My hAPI team is your road to success."

Dr. Marcus Hannakam

"Score with our know-how and services."

Dr. Gabi Ohlendorf

"Comprehensive regulatory support is my passion."

Ines zum Hebel

"Our R & D experts - your asset in all CMC phases."

Dr. Holger Rauter

Pharmaceutical Ingredients

Cancer cases are globally on the rise, causing an increasing demand for their treatment. Highly Potent Active Pharmaceutical Ingredients (hAPIs) are the key compounds for chemotherapies, combination therapies in particular​.
Heraeus Precious Metals Pharmaceutical Ingredients Business Line is specialized in the production of generic hAPIs as well as the exclusive synthesis of cytotoxic compounds from the research stage to registration to market launch.

Products and Services

Generic hAPIs

Generic hAPIs

The high purity of our active pharmaceutical ingredients guarantees our customers effective processes and consistently top quality for their products. Continuous enhancement of our knowledge enables them to maintain compliance with changing regulations and ensures a long-term drug supply.

CDMO

Contract Manufacturing of Highly Potent APIs (CDMO)

Many highly active ingredients require special handling, compelling manufactures to take appropriate protective measures. Heraeus with its broad experience in chemistry, processes and the appropriate equipment is a partner fully dedicated to the manufacturing of hAPIs.

Custom Manufacturing

Cancer cases are steadily on the rise across the globe. Highly active pharmaceutical ingredients (hAPIs) are the key compounds and most relevant to combination therapies in particular. Both developing new active ingredients and optimizing lab syntheses for mass production require the profound knowledge of experts. Moreover, hAPIs have to be handled in high-containment facilities with extreme care.

Heraeus has the appropriate equipment and extensive experience in dealing with such challenging molecules. We support our customers in the exclusive synthesis of cytotoxic compounds from the research stage to registration and market launch. With these comprehensive services, customers are free to focus on their core business and to transform their innovative ideas into commercial products.

More than 40 years of expertise in the field of cytotoxic hAPIs is the foundation of our exclusive contract development and manufacturing services (CDMO). Therefore,

  • Heraeus' high-containment systems (OEL < 10 ng/m3) ensure the highest technological standard.
  • Scientists and experts contribute extensive knowledge and experience to each project.
  • Contract manufacturing includes batches from gram to fully commercial scale.
  • With comprehensive GMP documentation and outstanding global regulatory support we offer the full-service package.
  • Heraeus strictly protects customers’ IP.

With our comprehensive knowledge in process chemistry and project management, we always create tailor-made offers to you as our clients and guarantee time-efficient and cost-effective solutions for any challenges you may face.

Quality Competence

Quality Competence

Extensive analytical capabilities, quality assurance and the full reliability of a global partner are extremely important for the pharmaceutical industry. Heraeus constantly secures the quality of highly active pharmaceutical ingredients, strictly follows international regulations and prepares and maintains all documentation for initial and existing registrations worldwide.

Regulatory Affairs

Regulatory Affairs

A successful registration based on transparent communication not only permits entry to markets all over the world; it also confirms that Heraeus meets the strictest requirements for the quality of its hAPIs.

Preparation of Dossiers

  • registration documents according to current ICH standards
  • all relevant pharmacopeias (e.g. Ph. Eur., BP, USP, JP, IP, CP)
  • chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part - also based on customers’ raw data
  • CEPs available for all hAPIs with a pharmacopeial monograph
  • expertise in eCTD submissions and non-eCTD electronic submissions (NeeS)

Management of Registration Procedures

  • registration procedures consistent with current guidelines and predetermined timeframes
  • assistance in providing additional technical information
  • competent personal contact at all stages of the registration process

Life Cycle Management

  • regulatory support for existing products
  • continuous improvement of documentation
  • established change control system
  • professional change management with customers and authorities in line with the current Variation Regulations

Quality Assurance

Quality Assurance

Heraeus constantly secures the outstanding quality of its highly active pharmaceutical ingredients and ensures a continuous improvement of quality, safety and environmental standards through its comprehensive services:

  • Release of hAPIs
  • Supervision of GMP compliance & quality
  • GMP compliant document management
  • Auditing of internal departments as well as external suppliers
  • Training of staff and management
  • QA agreements

Quality Control

Quality Control

Heraeus is equipped with the most state-of-the-art analytical techniques: process controls, analysis of raw materials, intermediates, and release testing of hAPIs are conducted in compliance with cGMP and ICH guidelines.

Our Services

  • Release of raw materials
  • Quality control of intermediates, in-process controls and hAPIs
  • Stability testing of hAPIs and raw materials (if required)
  • Full characterization and qualification of reference standards
  • Development and validation of analytical methods
  • Identification of unknown impurities / degradation products

Contact

Get in touch with us!

Dr. Gabi Ohlendorf
Sales

Dr. Gabi Ohlendorf

Global Head of Marketing & Sales, Pharmaceutical Ingredients
Dr. Felix Held Heraeus
Sales

Dr. Felix Held

Project Manager New Business Pharmaceutical Ingredients